Within the fields of clinical research for pharmaceuticals, medical devices, and biologics, there are many electronic data collection and operational support systems known as clinical trial management systems or electronic data capture systems. Generally, in the patient recruitment process a company with a product, such as, but not limited to, a pharmaceutical company with a new drug, or a medical device company with a new medical device, have studies, also referred to as trials, that require completion to a degree of regulatory satisfaction. Such regulatory satisfaction may be as determined by organizations such as the Food and Drug Association (FDA). The company contracts with investigational sites for the completion of the studies, while the investigational sites are responsible for recruiting patients, having the studies completed, and reporting results of the studies.
Presently available systems address many aspects of interest to clinical research operations and management professionals, however, the solutions do not address the information-collection and process-management requirements of complex, multinational physician and patient recruitment, enrollment, and retention elements of their work.
Thus, a heretofore unaddressed need exists in the industry to address the aforementioned deficiencies and inadequacies.